Label: MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15 CHAMOMILE- zinc oxide and titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 28, 2014

If you are a consumer or patient please visit this version.

View All Sections
  • Unit Carton

    Unit Carton

  • Tube

    Tube

  • ACTIVE INGREDIENT

    Titanium Dioxide 4.5%

    Zinc Oxide 3.0%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    Helps prevent sunburns

    If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • BOXED WARNING (What is this?)

    Warnings

    Warnings

    For external use only

    Do not use on damages or broken skin

    Stop use and ask a doctor if rash occurs

    When using this product keep out of eyes. Rinse with water to remove.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

  • DOSAGE & ADMINISTRATION

    Directions

    apply liberally 15 minutes before sun exposure

    use a water resistant sunscreen if swimming or sweating: Immediately after towel drying.

    reapply at least every 2 hours.

    Children under 6 months. Ask a doctor

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer

    and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad

    Spectrum SPF value of 15 or higher and other sun protection measure including:

    limit time in the sun, especially from 10 a.m. to 2 p.m.

    wear long-sleeved shirts, pants, hats, and sunglasses

  • OTHER SAFETY INFORMATION

    protect this product from excessive heat and direct sun.

  • ADVERSE REACTIONS

    -you may report a serious adverse reaction to Jouer Customer support, toll free: 1-800-315-5374, M-F, 8am-6pm PST (US and Canada Only)

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER (AQUA), CYCLOPENTASILOXANE, OCTYLDODECYL NEOPENTANOATE, BUTYLENE GLYCOL, POLYGLYCERYL-4 ISOSTEARATE, DIMETHICONE CROSSPOLYMER, PEG/PPG 18/18 DIMETHICONE, SILICA, DIMETHICONE, CETYL PEG/PPG-10/1 DIMETHICONE, STEARIC ACID, ALUMINUM HYDROXIDE, SODIUM DEHYDROACETATE, PHYTANTRIOL, HEXYL LAURATE, TRIETHOXYCAPRYLYLSILANE, NYLON-12, SODIUM CHLORIDE, RETINYL PALMITATE, TOCOPHEROL, TETRAHEXYLDECYL ASCORBATE, POLYDODECANAMIDEAMINIUM TRIAZADIPHENYLETHENESULFONATE, POLYVINYLALCOHOL CROSSPOLYMER, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, ZINC CHLORIDE, LYSINE, SODIUM HYALURONATE, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, ISOPROPYLPARABEN, POTASSIUM SORBATE. MAY CONTAIN (+/-): MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499).

  • INGREDIENTS AND APPEARANCE
    MATTE MOISTURE TINT SUNSCREEN BROAD SPECTRUM SPF 15  CHAMOMILE
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69017-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 mg  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.0 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    NYLON-12 (UNII: 446U8J075B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    LYSINE (UNII: K3Z4F929H6)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOPROPYLPARABEN (UNII: A6EOX47QK0)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69017-204-021 in 1 BOX
    1NDC:69017-204-0150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2014
    Labeler - Jouer Cosmetics LLC (011002088)
    Registrant - Jouer Cosmetics LLC (011002088)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Boxed Warnings, Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!